About this trial
Randomized split mouth clinical trials study focused on comparing the efficacy of C-PRF/ Hyaluronic acid combination versus C-PRF injection alone in subjects with thin gingival phenotype.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Systemically healthy male or female adults aged 20 to 40 years.
Non-smoker.
Presence of a clinically thin gingival phenotype (gingival thickness ≤ 1.0 mm) at the targeted surgical sites.
Presence of bilateral homologous teeth (e.g., both maxillary canines, or both mandibular first premolars) exhibiting the same thin gingival phenotype to allow for paired test and control sites within the same oral cavity.
Disqualifiers
Any systemic disease or condition known to compromise wound healing or alter immune response (e.g., uncontrolled diabetes mellitus, autoimmune disorders, bleeding dyscrasias).
Current or recent use of medications known to induce gingival enlargement (e.g., phenytoin, cyclosporine, calcium channel blockers) or medications affecting blood coagulation and platelet function (e.g., anticoagulants) within last 10 days of the procedure.
Active periodontitis, defined by probing depths > 3 mm or bleeding on probing at the designated experimental sites
Any previous history of mucogingival surgery, soft tissue grafting, or local trauma at the selected test or control sites.
Trial design
Single group
Treatments tested in this trial
C-PRF and Hyaluronic Acid
Other interventionA mixed preparation consisting of 0.5 mL of Concentrated Platelet-Rich Fibrin (C-PRF) and 0.5 mL of 1.6% cross-linked hyaluronic acid, 0.2% natural Hyaluronic Acid. The mixture is administered via direct subepithelial injection at the mucogingival junction of the target teeth using a 30-gauge needle. 3 injections sessions with 10 days intervals and baseline, 3 months and 6 months follow up visits.
C-PRF
Other intervention1 mL of Concentrated Platelet-Rich Fibrin (C-PRF) is administered via direct subepithelial injection at the mucogingival junction of the target teeth using a 30-gauge needle. 3 injections sessions with 10 days intervals and baseline, 3 months and 6 months follow up visits.
Treatment groups
Trial outcomes
Primary outcomes
Changes in Gingival Thickness & Keratinized Tissue Width at baseline and at 6 months after the injection of C-PRF/ Hyaluronic acid
Using Trans-ginval probing method to measure the gingival thickness and using Periodontal probe with 1 mm markings to measure the keratinzed tissue width, we measure the difference between the baseline and 6 month after the injection of C-PRF/ Hyaluronic acid and compare the readings with the other side that would be injected with C-PRF alone. (To make the assessments repeatable, we will fabricated a stent for each participant. Each stent has a specific hole to measure the gingival thickness through it in order to make the readings as accurate as possible and all the measurements will be in mm scale).
Sponsors and contacts
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Sajjad Ahmed Shakir
Lead sponsor
University of Baghdad
Sponsor institution
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